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Outcomes in patients with aggressive or refractory disease from REVEL: A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non-small-cell lung cancer
- Source :
- Lung cancer (Amsterdam, Netherlands). 112
- Publication Year :
- 2017
-
Abstract
- Objectives The REVEL study demonstrated improved efficacy for patients with advanced non-small cell lung cancer treated with ramucirumab plus docetaxel, independent of histology. This exploratory analysis characterized the treatment effect in REVEL patients who were refractory to prior first-line treatment. Materials and methods Refractory patients had a best response of progressive disease to first-line treatment. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and safety. Kaplan-Meier and Cox proportional hazards regression were performed for OS and PFS, and Cochran-Mantel-Haenszel test was used for response. QoL was assessed with the Lung Cancer Symptom Scale. Sensitivity analyses were performed on subgroups of the intent-to-treat population with limited time on first-line therapy. Results Of 1253 randomized patients in REVEL, 360 (29%) were refractory to first-line treatment. Baseline characteristics were largely balanced between treatment arms. In the control arm, median OS for refractory patients was 6.3 versus 10.3 months for patients not meeting this criterion, demonstrating the poor prognosis of refractory patients. Median OS (8.3 vs. 6.3 months; HR, 0.86; 95% CI, 0.68–1.08), median PFS (4.0 vs. 2.5 months; HR, 0.71; 95% CI, 0.57–0.88), and ORR (22.5% vs. 12.6%) were improved in refractory patients treated with ramucirumab compared to placebo, without new safety concerns or further deteriorating patient QoL. Conclusions The effect of ramucirumab in refractory patients is similar to that in the intent-to-treat population. The benefit/risk profile for refractory patients suggests that ramucirumab plus docetaxel is an appropriate treatment option even in this difficult-to-treat population.
- Subjects :
- 0301 basic medicine
Oncology
Refractory patient
Male
Cancer Research
Lung Neoplasms
Phases of clinical research
non-small cell lung cancer (NSCLC)
Docetaxel
Kaplan-Meier Estimate
0302 clinical medicine
Phase 3 clinical trial
Refractory patients
Carcinoma, Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
Aged, 80 and over
education.field_of_study
Antibodies, Monoclonal
Middle Aged
Clinical trial
Angiogenesi
Treatment Outcome
030220 oncology & carcinogenesis
Retreatment
Disease Progression
Female
Taxoids
medicine.drug
Pulmonary and Respiratory Medicine
Adult
medicine.medical_specialty
Histology
Population
Non-small cell lung cancer (NSCLC)
Antibodies, Monoclonal, Humanized
Ramucirumab
03 medical and health sciences
Young Adult
Refractory
Internal medicine
medicine
Humans
education
Lung cancer
non-small cell lung cancer
Aged
Neoplasm Staging
business.industry
Vascular endothelial growth factor (VEGF)
medicine.disease
Human monoclonal antibody
030104 developmental biology
Drug Resistance, Neoplasm
Quality of Life
Angiogenesis
Vascular endothelial growth factor
business
Progressive disease
Subjects
Details
- ISSN :
- 18728332
- Volume :
- 112
- Database :
- OpenAIRE
- Journal :
- Lung cancer (Amsterdam, Netherlands)
- Accession number :
- edsair.doi.dedup.....439df97481e7696d63c69cab84d7ea41